Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Neurology ×
6,334 results
865–888 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Apr 13, 2022
Bendit21 Microcatheter
K203842 · QJP
Bend IT Technologies, Ltd.
Neurology · 468d
Cleared Apr 12, 2022
PROWLER SELECT LP ES Microcatheter
K214025 · KRA
Medos International SARL
Neurology · 111d
Cleared Apr 12, 2022
ClearPoint Array System (version 1.1)
K214040 · HAW
ClearPoint Neuro, Inc.
Neurology · 110d
Cleared Apr 08, 2022
visor2 system
K210109 · HAW
Eemagine Medical Imaging Solutions GmbH
Neurology · 444d
Cleared CT Apr 06, 2022
Onera Sleep Test System (Onera STS)
K210593 · MNR
Onera B.V.
Neurology · 401d
Cleared Apr 06, 2022
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
K220625 · OBP
Remed Co., Ltd.
Neurology · 34d
Cleared Apr 01, 2022
TENS and EMS Stimulation (OTC)
K212184 · NUH
Changsha Yuwen Medical Equipment Co.,...
Neurology · 262d
Cleared Apr 01, 2022
TENS & PMS Unit
K220005 · NUH
Shenzhen Yuehua Xinsen Technology...
Neurology · 87d
Cleared CT Mar 31, 2022
ERIC Retrieval Device
K211120 · NRY
MicroVention, Inc.
Neurology · 350d
Cleared Mar 31, 2022
PediGuard Threaded
K220160 · PDQ
Spineguard S.A.
Neurology · 71d
Not Cleared Mar 29, 2022
BrainTemp Neonate System (BTNeo System)
DEN200042 · QSL
Brain Temp, Inc.
Neurology · 644d
Cleared Mar 24, 2022
FUBUKI XF Neurovascular Long Sheath
K213589 · QJP
Asahi Intecc Co., Ltd.
Neurology · 132d
Cleared Mar 18, 2022
Needle Stimulator (Model: RJNS6-1)
K220153 · BWK
Bozhou Rongjian Medical Appliance...
Neurology · 58d
Cleared Mar 15, 2022
CerusEndo Microcatheter (027)
K213314 · QJP
Cerus Endovascular, Inc.
Neurology · 162d
Cleared Mar 11, 2022
Personal Kinetigraph (PKG) System Gen 2 Plus
K211887 · GYD
Gkc Manufacturing Pty, Ltd.
Neurology · 263d
Cleared Mar 11, 2022
Intracept Intraosseous Nerve Ablation System
K213836 · GXI
Relievant Medsystems, Inc.
Neurology · 92d
Cleared Mar 09, 2022
SafeOp 2: Neural Informatix System
K213849 · GWF
Alphatec Spine, Inc.
Neurology · 89d
Cleared Mar 04, 2022
BTL-995-rTMS
K212723 · OBP
BTL Industries, Inc.
Neurology · 189d
Cleared Mar 02, 2022
Sugita AVM Microclips
K211183 · HCH
Mizuho America, Inc.
Neurology · 316d
Cleared Feb 24, 2022
Luminice
K214100 · NFO
Premier North America, Inc.
Neurology · 57d
Cleared Feb 23, 2022
StimRouter Neuromodulation System
K211965 · GZF
Bioness, Inc.
Neurology · 244d
Cleared Feb 19, 2022
Well-Life TENS/EMS/Heating Stimulator
K213091 · NUH
Well-Life Healthcare Limited
Neurology · 148d
Cleared Feb 17, 2022
TENS & PMS (Model: SM9126)
K220150 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 29d
Cleared Feb 14, 2022
Cionic Neural Sleeve NS-100
K213622 · GZI
Cionic
Neurology · 90d